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Completed

NCT Number: NCT02442908

Pilot Study of Safety and Tolerability of Nutrifriend Cachexia in COPD Cachexia

SF-K002 is a pilot study in patients with moderate to severe COPD suffering from involuntary weight loss. The study is 12 weeks, double-blinded, placebo controlled and the main objective is to study the safety and tolerability of Nutrifriend Cachexia.

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Key information

Conditions

COPD Body Weight Body Weight Changes Cachexia Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Thinness Weight Loss

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ladulaas kliniska studier, Borås, Sweden

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About this study

This study is a 12-week, randomised, parallel group, placebo controlled, multi-centre study. The primary objective is to evaluate the safety and tolerability of Nutrifriend Cachexia in patients with COPD. The secondary objectives of the study are to evaluate effects on body composition, muscle function, daily activity, inflammation, lung function, compliance, appetite and Quality of Life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >50 years
  • Moderate to severe COPD patients with forced expiratory volume (FEV1) of 30-60%
  • Involuntary weight loss <10%
  • 18 kg/m2 ≤ BMI ≤ 32 kg/m2

Exclusion criteria

  • Exacerbation of COPD within 3 months prior to screening
  • Treatment with oral corticosteroids (>5 mg/day) within 3 months prior to screening
  • Treatment with anabolic steroids within 3 months prior to screening
  • Current oxygen treatment or home ventilation therapy
  • Change in smoking habits during the previous 6 months
  • Major changes in COPD maintenance treatment within 3 months prior to screening
  • Other cachectic disorders such as cancer, renal or hepatic disorders

Treatment and study plan

Nutrifriend Cachexia

Dietary Supplement

2 daily for 12 weeks

Other names: NFCax

Isocaloric placebo

Dietary Supplement

2 daily for 12 weeks

Other names: Placobo

Primary outcomes

  1. Safety and tolerability assessed by (adverse events, concomitant medication and laboratory markers) of Nutrifriend Cachexia in patients with COPD

    Time frame: 12 weeks

Secondary outcomes

  1. Body composition assessed by fat mass and lean body mass (LBM)

    Time frame: 12 weeks

  2. Body composition assessed by weight, BMI and waist & calf circumference

    Time frame: 12 weeks

  3. Function assessed by 6 minute walking test

    Time frame: 12 weeks

  4. Function assessed by grip strength

    Time frame: 12 weeks

  5. Function assessed by walking distance

    Time frame: 12 weeks

  6. Inflammation

    Time frame: 12 weeks

    IL-6, IL-8, TNF-alpha, CRP

  7. Metabolic markers

    Time frame: 12 weeks

    Glucose, insulin, cholesterol

  8. QoL assessed by COPD Assessment Test (CAT)

    Time frame: 12 weeks

  9. QoL assessed by COPD Clinical Questionnaire (CCQ)

    Time frame: 12 weeks

  10. QoL assessed by St. George Respiratory Questionnaire for COPD patients (SGRQ C)

    Time frame: 12 weeks

  11. QoL assessed by Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire

    Time frame: 12 weeks

  12. QoL assessed by Nutrition Appetite Questionnaire (CNAQ)

    Time frame: 12 weeks

  13. Compliance assessed by Drinks consumed

    Time frame: 12 weeks

  14. Compliance assessed by vitamin D levels

    Time frame: 12 weeks

  15. Compliance assessed by Omega-3 incorporation

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Smartfish AS

Industry

Registry information

Official study title

A 12-Week, Randomised, Placebo Controlled, Multi-Centre, Parallel Group Study Assessing the Safety and Tolerability of Nutrifriend Cachexia (Non-Complete Dietary Formula) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 13, 2015
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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